Data / Medical devices / United States / Greater Goods, LLC
Greater Goods, LLC: FDA-registered device maker in Saint Louis, MO, United States, 18 510(k) clearances
Greater Goods, LLC is registered with the FDA (registration 3011065399) in Saint Louis, MO, United States. It lists 14 device types. The FDA files 18 510(k) clearances under its listings, the newest dated August 21, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011065399
- Address
- 4427 Chouteau Ave, Saint Louis, MO, United States, 63110
- Owner or operator
- Greater Goods, LLC / Design Manufacture Distribution LLC (10047365)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- August 18, 2014
- Registered through
- 2026
- Brand names listed
- 0003 Bluetooth Pulse Oximeter (RPM), 0004 Bluetooth Blood Glucose Monitor, 0022/ 0375/ 0376/ 0383/ 0393/ 0402/ 0378/ 0382/ 0343/ 0380 Greater Goods Body Composition Scale, 0030 Blood Glucose Monitor (RPM), 0040 Bluetooth Blood Pressure Monitor, 0042 Cellular Blood Pressure Monitor, 0043 Cellular Blood Pressure Monitor, 0053 Body Comp Bathroom Scale and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 21, 2024 | K241351 | Blood Pressure Monitor (TMB-2092-G) | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| April 29, 2024 | K240102 | Blood Pressure Monitor (TMB-2287-B) | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| June 28, 2023 | K223722 | MIO Blood Glucose Monitoring System | NBW | Substantially Equivalent | Mio Labs, Inc. | accessdata.fda.gov |
| July 6, 2022 | K220475 | Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) | QRL | Substantially Equivalent | Tianjin Huahong Technology Co., Ltd. | accessdata.fda.gov |
| March 9, 2021 | K202891 | Blood Pressure Monitor | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| June 12, 2020 | K200521 | Full Automatic(NIBP) Blood Pressure Monitor | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| October 18, 2019 | K191430 | Pulse Oximeter | DQA | Substantially Equivalent | Shenzhen Yimi Life-Technology Co., Ltd. | accessdata.fda.gov |
| December 19, 2018 | K173140 | VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring System | NBW | Substantially Equivalent | Vivachek Laboratories, Inc. | accessdata.fda.gov |
| April 19, 2018 | K172427 | AViTA Radar Thermo NT16 Series IR Thermometer | FLL | Substantially Equivalent | Avita Corporation | accessdata.fda.gov |
| September 19, 2017 | K163518 | Digital Thermometer | FLL | Substantially Equivalent | Joytech Healthcare Co. , Ltd. | accessdata.fda.gov |
| August 28, 2015 | K151206 | Fingertip Pulse Oximeter | DQA | Substantially Equivalent | Beijing Choice Electronic Technololgy Co., Ltd. | accessdata.fda.gov |
| June 19, 2013 | K131395 | TRANSTEK BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| May 30, 2013 | K130311 | TRANSTEK BODY FAT ANALYZER | MNW | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| December 21, 2012 | K123669 | TRANSTEK WRIST BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Zhongshan Transtek Electronics Co., Ltd. | accessdata.fda.gov |
| October 22, 2012 | K122482 | TRANSTEK WRIST BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Zhongshan Transtek Electronics Co., Ltd. | accessdata.fda.gov |
| May 3, 2012 | K120351 | CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| January 31, 2012 | K120058 | TRANSTEK BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Zhongshan Transtek Electronics Co., Ltd. | accessdata.fda.gov |
| April 9, 2009 | K090014 | CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPE | DXQ | Substantially Equivalent | Caremate Medical Device Co., Ltd. | accessdata.fda.gov |
Compare with other makers
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- All makers of System, Test, Blood Glucose, Over The Counter
Updated August 21, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.